IVDR/LDT Support for Global Clinical Trials
IVDR/LDT - Enabled Support for Global Clinical Trials
A compliant path when key biomarkers remain RUO in the EU
Sponsors running global clinical trials often face a practical constraint: biomarkers accepted in one region may remain Research Use Only (RUO) in the EU, limiting their use in clinical trial decision-making.
MLM Medical Labs provides a regulatory-aligned solution.
As a Health Institution under the EU IVDR, MLM enables the validation and use of Laboratory Developed Tests (LDTs) for clinical research—supporting aligned clinical decisions across global trials.
Operating Today Within a Framework Others Are Still Discussing
MLM’s IVDR/LDT support is grounded in established regulatory status and operational capability.
As a recognized Health Institution, MLM operates within the IVDR framework to support clinical research needs in the EU. This enables MLM to:
- Validate specific biomarker assays as LDTs under IVDR
- Perform those tests for medical decision making in clinical trials in the EU
- Support global trial execution without fragmenting biomarker strategies
- Provide continuity of data across regions and trial phases
Health Institution Status Under IVDR
Under IVDR, only Health Institutions are permitted to develop and use LDTs for clinical research, and MLM qualifies as a Health Institution.
As such, MLM Medical Labs enables:
- IVDR-aligned LDT validation
- High-quality, reproducible biomarker data
- Regulatory-compliant support for clinical trials conducted in the EU
This status provides Sponsors with clarity and confidence when navigating EU regulations in global studies.
Disease-Agnostic. Trial-Focused. Regulatory-Ready.
MLM’s IVDR/LDT positioning is not limited to a single indication.
It applies broadly to global clinical trials where:
- Biomarkers evolve faster than regulatory approvals
- CE-marked diagnostics are not yet available
- Trial decisions depend on fit-for-purpose assays
This includes programs across:
- Inflammatory and autoimmune disease
- Metabolic and cardiovascular research
- Oncology and precision medicine
- Neurodegenerative and rare diseases
WHY THIS MATTERS NOW
MLM’s IVDR/LDT capability allows Sponsors to:
- Move forward
- Maintain global alignment
- Reduce operational workarounds
- Avoid unnecessary delays tied to CE-mark timelines
This approach supports practical execution within the current regulatory framework.
Let’s Discuss the Path from RUO to LDT
Reach out today to learn how MLM assesses biomarker fit-for-purpose and IVDR/LDT validation for use in EU clinical trials.
